Research

CLINICAL TRIALS

Prostate Cancer

Phase II Randomized, Placebo-Controlled Trial of PROSTVAC (PSA-TRICOM) in Patients with Clinically Localized Prostate Cancer Undergoing Active Surveillance (DCP Protocol #: UAZ2014-03-01)


Phase II.

Eligibility:
People with prostate cancer who are followed by active surveillance may join. Inclusion criteria include: Biopsy-proven adenocarcinoma of the prostate with less than equal to 50% of the cores positive for cancer, clinical stage less than equal to T2a, Gleason score less than equal to (3+4) equal to 7; confirm availability of pre-study biopy tumore tissue; screening serum PSA less than 15 ng/mL. Exclusion criteria include: no prior treatment for prostate cancer by surgery, irradiation, local ablative, or androgen-deprivation therapy; no distant metastases; no immunodeficiency.

Overview:
This study has two study groups. Group 1 will receive the study vaccine PROSTVAC and Group 2 will receive a placebo by random assignment. Two-thirds of the participants will be placed in Group 1 and one-third in Group 2 within 90 days and once you are determined to be eligible after the Screening Visit, an injection of the priming vaccine or placebo will be given at the Baseline Visit. You will need to avoid close contact with the following individuals for 3 weeks after the priming injection: children less than equal to 3 years of age, immunocompromised individuals, individuals with skin disorders, and pregnant or breast feeding women. During the study, you will return to the clinic at 2, 4, 8, 12, 16, and 20 weeks after the Baseline Visit for booster vaccine or placebo. There is no risk of infecting immunocompromised individuals with the booster vaccines so no contact restriction. Post Intervention Visit will take place 1-2 weeks after the last vaccine, including the post-intervention prostate biopsy as part of your routine care.

PI: Dr. Christian Pavlovich

Contact Name: Lucinda Robinson, RN
Phone: 410 550-9589

TULSA-PRO therapy for MRI-guided minimally-invasive whole gland ablation of low and low-intermediate risk prostate cancer 


Phase 0.

Eligibility:
An international multi-institutional trial of a new minimally-invasive transurethral ultrasound technology for prostate ablation, open to men with previously untreated low to low-intermediate grade prostate cancer. Some of the eligibility criteria:  
 
1. Male, age 45 to 80 years 
2. Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before study (or at the discretion of PI and approval by the Sponsor) 
3. Clinical stage ≤ T2b 
4. Gleason score ≤ 3 + 4 
5. PSA ≤ 15 ng/ml 
6. Eligible for MRI 
7. Eligible for general anesthesia 
8. Prostate volume ≤ 90 cc on baseline MRI

Overview:
The Johns Hopkins School of Medicine is happy to announce the opening of this new pivotal trial for the use of Transurethral Ultrasound Prostate Ablation (TULSA) for the treatment of localized low and low-intermediate risk prostate cancer.  The TULSA-Pro device is being studied as a minimally-invasive, MRI-guided approach to treat prostate cancer.  If you are interested, you can read more about the trial either on our national clinical trials registration site (https://clinicaltrials.gov/ct2/show/NCT02766543) or by visiting http://www.profoundmedical.com/

PI: Dr. Pavlovich

Contact Name: Carolyn Chapman, BA, RN
Phone: (443) 287-7841
Email: cchapma7@jhmi.edu


NCT02489357: Pembrolizumab and Cryosurgery in Treating Patients with Newly Diagnosed, Oligo-metastatic Prostate Cancer


Overview:
Traditionally, men with metastatic (wide spread) prostate cancer were treated with hormonal deprivation. This therapy can extend survival but, in most men, the prostate cancer will adapt and the disease will progress. Immunotherapies (which harness the power, specificity, and adaptability of the immune system) carry with them a potential for disease cure even in the advanced state. This study investigates the combination of immune-stimulatory prostate cryosurgery and Pembrolizumab with standard of care androgen deprivation to achieve therapeutic responses in men with newly diagnosed low volume (less than 5 lesions) metastatic prostate cancer.

PI: Ashley E. Ross MD PhD

Contact Name: Ashley E. Ross MD PhD
Phone: 443-287-7225
Email: aross2@jhmi.edu


PSMA Imaging with 18F-DCFPyL PET/CT To Allow for Improved Identification of Prostate Cancer After Surgery


Overview:
18F-DCFPyL is a novel low-molecular weight PET imaging agent which was developed to target prostate cancer cells which overexpress a protein known as PSMA (prostate specific membrane antigen). In an attempt to aid clinicians in managing patients with a PSA-only recurrence after radical prostatectomy we are investigating the accuracy of 18F-DCFPyL PET/CT in this clinical context. With this information, physicians have been able to customize treatment plans for these patients.


Supplementation Trial of Vitamin E in Prostate Cancer Patients (STEP)


Overview:
Patients will be randomly assigned to take Vitamin E or placebo to determine if Vitamin E can change biological markers that may be important in causing prostate cancer.

PI: Drs. H. Ballentine Carter & HanYao Huang


Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate


Treatment trial.

Eligibility:
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Male Accepts Healthy Volunteers: No

Overview:
This will be a Phase II study evaluating the effectiveness and toxicity of a regimen of 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens of 2.5 Gy, 2.7 Gy, and 3.0 Gy daily fractions. The total dose is calculated to be iso-effective for late effects to a conventionally fractionated total dose of 81 Gy, which has been shown to be effective and safe in a large prospective Phase II study. If the alpha/beta ratio for prostate is between 1.5-3.0, then this regimen should be at least as effective or more effective for tumor control than 81 Gy given in conventional fractions.

PI: Danny Song, MD

Contact Name: Contact: Shirl DiPasquale, RN
Phone: 410-614-1598
Email: sdipasq1@jhmi.edu


A study of allogeneic human bone marrow derived mesenchymal stem cells in localized prostate cancer


Prevention trial.

Overview:
The obiective of this study is to determine systemically infused allogenic bone-marrow derived mesenchymal stem cells(MSCs) home to sites of prostae cancer in men with localized adenocarcinoma of the prostate who are planning to undergo a prostatectomy. Secondary objective include safety and looking at changes in Sexual Health Inventory for Men (SHIM) and Expanded Prostate CAncer Index Composite (EPIC) surveys post-prostatectomy.


A parmacodynamic pre-surgical study of hedgehog pathway inhibition with LDE225 in men with high-risk localized prostate cancer


Overview:
This trial is designed as a randomized two-arm (LDE225/observation) open-label prospective clinical trial in men with localized high-risk priostate cancer undergoing radical-prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk os systeic disease progression, by comparing pre-surgical core-biopsy pecimens to tumor tissue harvedsted at the time of prostatectomy.

PI: Emmanuel Antonarakis


J1408 A phase 2 Study of Bicalutamide Plus Finasteride in Men with MRI Detectable Prostate Nodules Undergoing Active Surveillance


Prevention trial.

Overview:
The primary objective of this study are to determine the negative re-biopsy rate as determined by MRI/TRUS-fusion guided biopsy targeting the dominant nodule site defined by pre-treatment MRI following 90 days of combination bicalutamide plus finasteride. Secondary endpoints include rate of exit from active surveillance at two years, safety, and quality of life.

PI: Ken Pienta


Kidney Cancer

DISSRM (Delayed Intervention and Active Surveillance for Small Renal Masses) Registry


Eligibility:
This study is open to any patient with a small renal mass (less than 4cm) suspicious for kidney cancer. The registry catalogs outcomes for patients who choose either active surveillance (http://urology.jhu.edu/kidneycenter/kidney_cancer_treatment1.php) or surgical intervention. The DISSRM Registry was opened in 2009 and is the world's largest, ongoing active surveillance program for kidney tumors.

PI: Pierorazio


Neoadjuvant Nivolumab for Locally Advanced Kidney Cancer


Treatment trial.

Phase I.

Eligibility:
This study is for patients with large or locally advanced kidney tumors. Nivolumab is among a new class of immunotherapy medications that have shown incredible promise for patients with metastatic kidney cancer. Investigators at Johns Hopkins are offering the first trial of its kind in the world, offering nivolumab prior to high-risk patients prior to surgery. Patients with large tumors (greater than 7cm), enlarged lymph nodes or tumors with vascular invasion are eligible for the study.

PI: Allaf


Erectile Dysfunction

Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy


Eligibility:
Ages Eligible for Study: 40 Years to 70 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, PSA less than 10) between ages 40-70 preoperative IIEF (erectile function section) score equal or greater than 20 AUA symptom score less than 10 and no urinary incontinence Exclusion Criteria: Men with neurological disease IIEF score less than 20 high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10) spinal cord injury history of transurethral resection of prostate (TURP) or other prostate ablative procedures history of priapism, pelvic neuropathy, penile skin lesions/ulcers inability to understand and demonstrate device use instructions.

Overview:
Primary Outcome Measures: Recovery of erectile function following radical prostatectomy. [ Time Frame: 12 months post-radical prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler. Secondary Outcome Measures: Recovery of continence after radical prostatectomy [ Time Frame: 12 months post-prostatectomy ] [ Designated as safety issue: No ] Patients will visit with investigators. Physical examination will be performed, including genital exam for any signs of penile irritation. Study subjects will complete the IIEF, EPIC urinary and sexual domain, AUA, EHS, EDITS and TSS questionnaires. Penile length will be measured from pubis to corona of the glans penis (dorsally) and recorded in centimeter using a standard wooden ruler.

PI: Arthur L Burnett, MD, MBA

Contact Name: Robert L Segal, MD
Phone: 410-614-0241
Email: rsegal3@jhmi.edu


Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate and No Erectile Dysfunction


Eligibility:
Ages Eligible for Study: 30 Years to 60 Years Genders Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria mild-moderate erectile dysfunction-IIEF-EF score 13-25 no erectile dysfunction-IIEF-EF score equal or greater than 25 Exclusion Criteria Men with neurological disease IIEF score less than 13 Spinal cord injury History of priapism Pelvic neuropathy Post-prostatectomy Penile skin lesions or ulcers Inability to understand and demonstrate device use instructions

Overview:
Primary Outcome Measures: To assess daily or on-demand ease of use, and efficacy of the home use of the Viberect device by men with mild to moderate and no erectile dysfunction [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: No ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire Secondary Outcome Measures: To assess safety of using Viberect penile stiumulation for the treatment of mild-moderate ED [ Time Frame: 4 weeks after initiation of intervention ] [ Designated as safety issue: Yes ] After obtaining informed consent, the subjects will be instructed in the use of the Viberect device, and will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual/erotic thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary. They will fill out several validated questionnaires on week 4: Erection Hardness Scale (EHS), EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction), TSS questionnaire

PI: Arthur L Burnett, MD, MBA

Contact Name: Brian Le, MD
Phone: 410-614-0241
Email: ble6@jhmi.edu


Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy


Eligibility:
To be eligible for this study you must: •Be between the ages of 40 and 59 •Have localized prostate cancer •Be scheduled to have a bilateral nerve sparing radical prostatectomy at Johns Hopkins Hospital •Have intact erectile function •Have a sexual partner of at least 6 months

Overview:
This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for prostate cancer. Recent laboratory findings suggest, that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively.

PI: Arthur L. Burnett, M.D.

Contact Name: Irene Trueheart, R.N.
Phone: (443) 287-1011
Email: itruehe1@jhmi.edu


Use of Vaccum Erection Device for "Penile Rehabilitation"


PI: Arthur L. Burnett, M.D.

Contact Name: Irene Trueheart, R.N.
Phone: 443 287 1011
Email: itruehe1@jhmi.edu


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